[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438071":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":41,"locations":47,"responsibleParty":66,"collaborators":40,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":40,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":40,"studyType":81,"phases":82,"briefSummary":85,"conditions":86,"keywords":40,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sunshine Lake Pharma Co., Ltd.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Mitizodone Phosphate tablet 10mg","EXPERIMENTAL","Mitizodone Phosphate tablet 10mg ,orally,once daily for 8 weeks, then placebo,orally,once daily for 2 weeks.",[13],"Drug: Mitizodone Phosphate tablets",{"label":15,"type":10,"description":16,"interventionNames":17},"Mitizodone Phosphate tablet 20mg","Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 7 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then placebo,orally,once daily for 1 weeks.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Mitizodone Phosphate tablet 40mg","Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 40mg ,orally,once daily for 6 weeks, then Mitizodone Phosphate tablet 20mg ,orally,once daily for 1 weeks, then Mitizodone Phosphate tablet 10mg ,orally,once daily for 1 weeks.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo","ACTIVE_COMPARATOR","Placebo,tablet,orally,once daily for 10 weeks.",[27],"Drug: Placebo-matching tablets",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Mitizodone Phosphate tablets","Mitizodone Phosphate tablets will be administered with food.",[9,15,19],[35],"HEC113995PA•H2O",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Placebo-matching tablets","Placebo will be administered with food.",[23],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"gang wang, Ph.D","CONTACT","86-010-58303236","gangwangdoc@gmail.com",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Dongguan","Guangdong","523871","China","CN",{"type":56,"coordinates":57},"Point",[58,59],113.74866,23.01797,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":64,"phoneExt":40,"email":65},"Li Xue","+8676985315888","lixuelc@hec.cn",{"type":67,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100438071","phase-2-the-efficacy-and-safety-of-mitizodone-phosphate-tablets-in-the-treatment-of-patient-with-major-depressive-disorder-100438071",false,"NCT04984512","The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder","A Phase II\u002FIII ,Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Adaptive Design Study Evaluating the Efficacy And Safety of Mitizodone Phosphate Tablets in the Treatment of Patient With Major Depressive Disorder","Inclusion Criteria:\n\n* 1.a Man or a woman with major depressive disorder(MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (classification code 296.22、296.23、296.32、296.33)\n* 2.Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.\n* 3.Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.\n\nExclusion Criteria:\n\n* 1.has major depressive disorder with psychotic features according to the DSM-5.\n* 2.Current or history of: bipolar disorder、schizophrenia、anixety disorder、insomnia、any substance abuse or dependence and other psychiatry disorder as defined in the DSM-5.\n* 3.Current or history of a clinically significant neurological disorder (including epilepsy、Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease).\n* 4\\. has Serious body disease such as neurological disorders、cardiacvascular disorders、hepatic disorders、 renal disorders, blood system disorders and endocrine disorders.\n* 5\\. Current or history of cancer( except basal cell of the skin and preinvasive carcinoma of cervix uteri).\n* 6\\. Current or history of angle-closure glaucoma.\n* 7\\. has made a suicide behavior in the previous 1 year ，or has a score greater than or equal to 4 on item 10 (suicidal thoughts) of MADRS .\n* 8.has taken fluoxetine within 4 weeks prior to initial dosing.\n* 9\\. has taken other antidepressive medications or antipsychotic medications within 2 weeks prior to initial dosing.\n* 10.has psychotherap at Screening and\u002For Baseline Visits.\n* 11.has had physiotherapy within 3 months prior to initial dosing.\n* 12.Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.\n* 13.Has an alanine aminotransferase, aspartate aminotransferase level greater than 2 times the upper limits of normal；or total bilirubin， direct bilirubin，creatinine level greater than 1.5 times the upper limits of normal；or a thyroid stimulating hormone value outside the normal range.\n* 14.Has an abnormal electrocardiogram confirmed as clinically significant by the investigator.\n* 15.Has a history of severe allergies.","ALL","18 Years","65 Years",{"count":79,"type":80},600,"ESTIMATED","INTERVENTIONAL",[83,84],"PHASE2","PHASE3","This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of double-blinded treatment in phase 2 period and will be assessed by both efficacy and safety from 3 dose groups of Mitizodone Phosphate.The dose be found in phase 2 period will be evaluated on efficacy and safety when compared with placebo in phase 3 period with a duration of 8 weeks treatment.The target subjects are patients with MDD.",[87],"Depressive Disorder, Major","2026-04-29",{"date":90,"type":91},"2026-05-05","ACTUAL",{"date":93,"type":91},"2021-12-14",{"date":95,"type":80},"2027-11",{"name":5,"class":6},1]